Suture with toggle and delivery system

ABSTRACT

The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture&#39;s terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle. In either situation, after the needle pierces the bodily structure, tissue or organ, the tab, leg, depending wire tip or open loop wire segment coacts with the inboard portion of the bodily structure, tissue or organ, and, as the delivery needle is withdrawn, the toggle at the terminal end of the suture remains in the bodily structure, tissue or organ. The toggle is then fully deployed being generally U normally disposed (perpendicular) to the length or axial center line of the suture. When the suture has two suture toggles, one at each terminal end of a suture thread or suture wire body, the physician can easily deploy the suture toggles on either side of an arterial puncture site (for example), tie off the suture thread or suture wire body and thereby close the puncture.

[0001] This is a regular patent application based upon provisionalpatent application Ser. No. 60/143,555 filed Jul. 13, 1999, currentlypending.

BACKGROUND OF THE INVENTION

[0002] In order to pass a suture through a tubular organ or otherstructure in a body (a human body or an animal), it is necessary totraverse the bodily structure, tissue or organ completely and encirclethe area where the physician or medical technician wishes to place thesuture. This traverse and encircle method works well in situations whereeasy access is available to the structure, tissue or organ and the itemto be sutured is easily viewed by the physician. In limited accesssituations (for example, in laposcopic surgery, cardiac surgery andvascular surgery), the traverse and encirclement by sutures is oftentimes difficult, dangerous and at other times impossible.

[0003] As a further example, an attempt to suture a blood vessel througha small puncture wound is almost impossible. The direct suture of thearterial puncture is not possible.

[0004] The increasing utilization of minimally invasive surgicaltechniques has created a need for improved methods, suture systems andsuture placement devices under adverse conditions of limited access andlimited visibility of the suture site.

[0005] U.S. Pat. No. 5,053,046 to Janese discloses a dural sealingneedle. The dural ceiling needle includes a gelatin sealing compoundthat swells and sits between an impact cone cavity and an impact coneprotrusion. Wings spread out based upon the swelling of the gelatin sealand assist in the retention of the suture seal. U.S. Pat. No. 5,860,990to Nobles et al. discloses a suturing device which includes sutureshaving needle points at terminal ends of the suture wire. The suturesare made of NITINOL memory shape metal material. When the memory shapemetal is freed from the lumen of a needle, the needle points, at theterminal ends of the metal sutures, flare out laterally beyond the lumenof the needle and the needle points are captured by suture catches whichare also laterally disposed outboard of the needle. The catches pull theneedle points and draw in the sutures. U.S. Pat. No. 4,744,364 to Kenseydiscloses a tubular body at the end of a suture thread which expandsafter being pushed out from the lumen of a delivery needle. In thelumen, the body is contracted or compressed. U.S. Pat. No. 4,741,330 toHayhurst discloses an apparatus for anchoring cartilage. The anchor isdeformed in the lumen of a delivery tube, is thereafter pushed from thetube and springs laterally outward upon exiting the tube.

[0006] U.S. Pat. No. 4,705,040 to Mueller et al. disclose a T-shapedbar, having a length of 0.25 inches, at the end of a suture. The bar isheld in place by a melted ball of material at the terminal end of thesuture.

OBJECTS OF THE INVENTION

[0007] It is an object of the present invention to provide a suturewhich can be self secured on a bodily structure, tissue or organ with atoggle at the terminal end of the suture.

[0008] It is another object of the present invention to provide agenerally T-shaped toggle which latches on an interior or inboardsurface of a bodily structure, tissue and organ thereby permitting thebalance of the suture to be drawn in and wherein the toggle grasps thebodily structure, tissue and organ.

[0009] It is a further object of the present invention to provide atoggle configured as a bar at the end of a suture.

[0010] It is another object of the present invention to provide a metalwire suture with a T-shaped toggle or a toggle wire element attached tothe terminal end of a suture wire.

[0011] It is a further object of the present invention to provide asuture and a suture toggle wherein the suture toggle includes aprotruding leg or tab which is utilized by a needle delivery system toinsert the suture toggle into the bodily structure, tissue or organ.

[0012] It is a further object of the present invention to provide asuture delivery system including a slotted needle, within which isseated the leg or tab of the suture toggle, which assists in the processof inserting the suture toggle into the bodily structure, tissue ororgan.

[0013] It is another object of the present invention to provide a selfsecuring suture with a suture toggle which can be used for minimallyinvasive surgical techniques.

[0014] It is a further object of the present invention to provide asuture delivery system and toggle sutures utilized in laproscopicprocedures.

SUMMARY OF THE INVENTION

[0015] The self securing suture includes a suture having at least oneterminal end and a toggle, formed of suture material, at the suture'sterminal end. In one embodiment, the suture toggle is a bar. In anotherembodiment the suture is a wire and the toggle is a wire element toggle.The wire element toggle is a double strand segment or an open loopsegment. The suture delivery system includes a slotted needle configuredsuch that a protruding tab or leg of the toggle bar fits within slot ofthe needle. For wire sutures, the open loop wire element toggle fitswithin the slotted needles In another embodiment, a depending wire tip,from the wire element toggle, fits within the slot in the needle. Ineither situation, after the needle pierces the bodily structure, tissueor organ, the tab, leg, depending wire tip or open loop wire segmentcoacts with the inboard portion of the bodily structure, tissue ororgan, and, as the delivery needle is withdrawn, the toggle at theterminal end of the suture remains in the bodily structure, tissue ororgan. The toggle is then fully deployed being generally normallydisposed (perpendicular) to the length or axial center line of thesuture. When the suture has two suture toggles, one at each terminal endof a suture thread or suture wire body, the physician can easily deploythe suture toggles on either side of an arterial puncture site (forexample), tie off the suture thread or suture wire body and therebyclose the puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Further objects and advantages of the present invention can befound in the detailed description of the preferred embodiments whentaken in conjunction with the accompanying drawings in which:

[0017]FIGS. 1A and 1B diagrammatically illustrate a suture with a suturetoggle;

[0018]FIGS. 2A and 2B diagrammatically illustrate a suture deliveryneedle with and without the suture toggle;

[0019]FIGS. 3A, 3B, 3C, 3D and 3E diagrammatically illustrate theinsertion and deployment of the suture toggle and, more particularly,

[0020]FIG. 3E generally diagrammatically illustrates the sizerelationship between the suture toggle and a typical large artery in ahuman body;

[0021]FIGS. 4A, 4B and 4C diagrammatically illustrate a suture deliverysystem needle, a suture toggle and a modified delivery system;

[0022] FIGS. 5A-5F diagrammatically illustrate various protruding legs,tabs and other elements protruding from the suture toggle which assistin deployment of the suture toggle in the bodily structure;

[0023]FIGS. 5G and 5H diagrammatically illustrate various suture toggleswith depending tabs;

[0024]FIG. 6 diagrammatically illustrates a suture having two terminalends and two suture toggles;

[0025]FIG. 7 diagrammatically illustrates a suture with two suturetoggles, at both terminal ends of a suture thread, deployed about anarterial puncture site;

[0026] FIGS. 8A-8C diagrammatically illustrate other suture toggles;

[0027] FIGS. 9A-9B diagrammatically illustrate a suture delivery systemwith and without a suture toggle;

[0028]FIGS. 10A and 10B diagrammatically illustrate the deployment ofthe suture toggle illustrated in FIG. 8A;

[0029]FIGS. 11A, 11B and 11C diagrammatically illustrate other types oftabs protruding from suture toggles;

[0030]FIG. 12 diagrammatically illustrates a suture toggle deployed in asuture delivery needle;

[0031]FIGS. 13A and 13B diagrammatically illustrate a suture toggleconfigured as a cylinder with a protruding side leg;

[0032]FIG. 13C diagrammatically illustrates a suture toggle configuredas an angled T-bar deployed in a neddle;

[0033]FIGS. 14A and 14B diagrammatically illustrate one delivery systemfor the suture and suture toggle utilized in conjunction with minimallyinvasive surgery;

[0034]FIGS. 15A and 15B diagrammatically illustrate front and side viewsof the suture delivery needle;

[0035]FIGS. 16A, 16B and 16C diagrammatically illustrate variousconfigurations of the needle retention body or structure;

[0036]FIG. 16D is a cross-sectional view of the delivery system from theperspective of section line 16D′-16D″ in FIG. 14A;

[0037]FIG. 17 diagrammatically illustrates an arterial puncture site ina large artery in a human;

[0038]FIG. 18 diagrammatically illustrates another type of suturedelivery system;

[0039]FIG. 19 diagrammatically illustrates an exploded view of thesuture delivery system shown in FIG. 18;

[0040]FIGS. 20A, 20B, 20C and 20D diagrammatically illustrate crosssectional views of the delivery system shown in FIG. 19 from theperspective of the corresponding section lines in FIG. 19;

[0041] FIGS. 21A-21F diagrammatically illustrate various configurationsof wire sutures and wire toggle elements;

[0042] FIGS. 22A-22D diagrammatically illustrate needle delivery systemsfor the wire suture toggles;

[0043] FIGS. 23A-23C diagrammatically illustrate a laproscopic devicefor the suture toggle delivery system and

[0044]FIG. 23D is a cross-sectional view of a suture wire capture system(similar capture systems may be used with suture threads on the deliverysystems in FIGS. 14A and 18);

[0045] FIGS. 24A-24C diagrammatically illustrate major operational stepsto deploy suture toggles during laproscopic surgery with the deliverysystem shown in FIG. 23A; and,

[0046]FIGS. 25A, B, C and D diagrammatically illustrate a hooked wiresuture.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] The present invention relates to self securing sutures, that is,sutures having toggles at the suture's terminal end, and various suturedelivery systems.

[0048]FIGS. 1A, 1B, 2A and 2B diagrammatically illustrate sutures havingtoggles at the terminal end and a needle delivery system used inconjunction with the suture toggles. FIGS. 14A and 18 diagrammaticallyillustrate simple delivery systems for the suture toggles. FIGS. 21A, B,C, D, E and F show wire suture toggles and FIG. 23A shows a deliverysystem for laproscopic surgery or other type of surgery wherein thesurgeon seeks to suture fascia.

GENERAL PRINCIPLES

[0049] By utilizing the toggle principle, it is possible to enter thebodily structure, tissue or organ and fix one end of a suture to thestructure or tissue without encircling the area. If two separate togglesutures are fixated in this fashion, it becomes possible to tie thosesutures with ease without the need for blind encirclement of the area inquestion. The increasing utilization of minimally invasive surgicaltechniques and arterial puncture site repair has created a need forimproved methods of suture placement under adverse conditions ofvisibility and access.

[0050] The toggle principal lends itself well to the placement andfixation of sutures, ligaments, etc. In this approach, a suture or wireor other flexible attachment or closure device is passed through or intothe tissue in a closed state. The “closed state” refers to the suturetoggle deployed in the needle. Upon applying tension after the toggleleaves the needle tip, the toggle is positioned so that it cannotretrace the path through which it was applied or inserted by virtue ofthe fact that its shape and position will no longer allow egress fromthe bodily structure or tissue. Structures such as sutures or ligamentsattached to the toggle are thereby fixed. One general embodiment of thisinvention consists of a T-shaped attachment to the end of a suture ofthe either the same or different biocompatible material. The T bar isstiffer than the suture line, thread or wire and offers significantresistance to extraction from the bodily structure once deployed. Thesuture toggle design in fine wire allows the insertion of the toggle,but restricts the egress from the tubular structure. With respect towire sutures, provision is made for the applying or delivery device tosecure both wires together and close the defect by shortening the wireby the simple, but effective, expedient means of twisting the instrumentand its contained wires to secure them together. Provision is made toscore the wires at the appropriate location so that the wires divide orseparate upon twisting with a small, but secure, stub of twisted wire.In the alternative, a twisting and cutting instrument can be slid downthe two opposing wires after the applicator is removed and the wiresretained. This instrument would permit twisting and subsequent cuttingof the wires in a blind procedure.

BASIC DETAILS OF OPERATION

[0051] The applying device or delivery system consists of a small hollowcore needle which allows it to be passed over a guide wire which hasbeen retained at the puncture site. The delivery system contains twosmall hollow needles in opposition at just the right distance on eitherside of the guide wire and, thus, the puncture site. In anotheriteration, the needle can be solid with hollow small toggle suture endsfitted over the needle rather than through them. In the first design,the needles are designed to contain the toggles and the wire or sutures.When the instrument is slid over the guide wire and through the skinincision site of puncture it is advanced until it is against the vesselor structure sought to be closed by a suture. In the case of a vein orartery, a “flashback” tube can be utilized in advance of the needles todemonstrate that the instrument is in the proper position. In addition,the length and design of the “flashback tube” is such that it protectsthe far wall of the structure, preventing toggling of two wallssimultaneously. The restricted length of the hollow needles alsoprotects opposite walls of the artery or vein. A slide moves the twoneedles distally and then advances the needles through the vessel orstructure wall until the toggles are deposited in the blood vessel withtheir trailing suture or wire leading from the vessel. The hollow needlealso acts as a flashback tube bilaterally. The shape of the toggle, asdesigned, prevents egress from the vessel and traction on the wire orsuture “sets” the T of the toggle flush against or in the structurewall. The suture is then tied or the wire twisted as appropriate.

[0052] Different toggle designs are provided as shown in theaccompanying drawings. In this fashion, puncture wounds or other defectsmay be easily closed utilizing simple and inexpensive devices. The costof complicated closure devices has been a deterrent to the universalacceptance of these previous devices. The utilization of a simple,inexpensive disposable device should remove many of the impediments foruniversal useage. The concept of toggling sutures for closure is new,safe and simple to use.

[0053] In one of the embodiments presented here, fine, partiallyannealed wire sutures are utilized to simplify the process by permittingfastening by simple twisting of the wires by the instrument, instead ofhaving to resort to complex methods of tying. Scoring the wires at theappropriate distance allows them to break with twisting at apredetermined location leaving only a small wire stump on top of thestructure.

[0054] Any biocompatible material for the suture and suture toggle maybe used such as stainless steel wire, nylon sutures, or other syntheticbiocompatible material. The methods of tying the sutures may vary withthe materials used, but the toggling principle remains the same.

[0055]FIGS. 1A and 1B diagrammatically illustrate a suture 10 having asuture thread or suture body 12, a terminal end 13 and a toggle 14. FIG.1B shows a side view of suture toggle system 10. In the illustratedembodiment, toggle 14 is generally a solid rectangular shape having alength 1, a width w (FIG. 1B) and a depth d. The width w of the toggle14 is substantially similar to the outside diameter of the suture thread12 as shown in FIG. 1B. Toggle 14 has chamfered ends and edges, one ofwhich is chamfer edge 15. This chamfer reduces sharp edges. Further,toggle 14 includes an extending leg 16 protruding outboard away fromterminal end 13 of suture 12. Extending leg 16 defines, in combinationwith toggle body element 18, an open catch mouth 20 leading to anarrower throat 21. Mouth 20 has a gap size large enough to be capturedby a slot in the delivery needle discussed later. Leg 16 protrudes in adirection opposite the attachment of suture 12 to toggle 14.

[0056]FIGS. 2A and 2B diagrammatically show a suture delivery system 8which includes needle 24 having a lumen 26, a piercing terminal end 28and an open ended slot 30. Open ended slot 30, sometimes called a needletoggle slot herein, is open at the piercing end segment 28 of needle 24.In the illustrated embodiment, piercing terminal end segment 28(typically a sharp edge) of needle 24 is angularly disposed with respectto the axial center line of needle 24.

[0057] Toggle suture system 10 is shown as disposed in lumen 26 ofneedle 24 in FIG. 2B. Suture toggle 14, and particularly protruding leg16, is adapted to seat within slot 30 of needle 24.

[0058] FIGS. 3A-3D diagrammatically illustrate basic operationalcharacteristics of suture toggle system 10. Similar numerals designatesimilar items throughout all the drawings. In FIG. 3A, suture deliverysystem 8, consisting of needle 24 loaded with suture 12 and suturetoggle 14, approaches a bodily structure, tissue or organ wall 31. As anexample throughout the drawings (excepting drawings FIGS. 24A-24C),reference will be made to arterial wall 31. However, any type of bodilystructure, tissue or organ may be sutured using the suture toggle system10 discussed herein. Wall 31 is representative of other bodilystructures tissues and organs. Delivery system 8 approaches arterialwall 31 as shown by arrow 33. Piercing end 28 of needle 24 ultimatelypierces and enters arterial wall 31.

[0059]FIG. 3B diagrammatically shows that needle 24 has fully enteredand passed through arterial wall 31. At this point in time, blood flowis noted by a “flash” from the lumen 26 of needle 24. Other “flash back”systems may be utilized. See central tube 62 in FIG. 14A. This flash ofblood provides a visual indication to the physician that the needle 24has fully penetrated into the lumen of the artery or other structure.

[0060] In FIG. 3C, the physician is withdrawing needle 24 and protrudingleg 16 of toggle 14 is S caught on the inboard surface of arterial wall31. In FIG. 3D, needle 24 is withdrawn from arterial wall 31 and toggle14 and suture 12 is self secured in artery wall 31.

[0061]FIG. 3E diagrammatically illustrates the general proportional sizerelationship between artery wall 31, the artery in general, toggle 14and suture 12. To further illustrate one proposed embodiment of thesuture toggle, the following Exemplary Dimensional Table is provided.Exemplary Dimensional Table head length 0.10-0.12 mm head depth 0.020 mmOD suture 3/0 nylon suture length 18 inches head width 0.10-0.012 mm gap0.008 mm or more typical delivery needle 0.028 mm OD 0.023 mm ID 21gauge large artery size about 7 mm ID

[0062]FIG. 4A diagrammatically illustrates suture toggle 14 and suturethread 12 disposed in needle 24. Protruding leg 16 is also disposed inslot 30. However, suture thread 12A is disposed outside of needle lumen26. This is accomplished by providing a secondary slot 34 within whichpasses suture thread A. Secondary slot 34 is sometimes referred toherein as a suture slot in the needle.

[0063]FIG. 4B diagrammatically shows open ended suture slot 34 atterminal end 29 of needle 24. Terminal end 29 of needle 24 is part ofpiercing terminal end 28. In the illustrated embodiment, suture slot 34is opposite toggle slot 30 which retains, in a loaded mode, protrudingleg 16 of suture toggle 14. The position of the suture slot relative tothe toggle slot varies dependent upon the position of the protrudingleg, tab, wire element or loop on the suture toggle.

[0064]FIG. 4C diagrammatically shows needle 24 within which is loadedsuture toggle 14. Protruding leg 16 protrudes towards suture thread 12A.In this illustrated embodiment, slot 30 also operates as a suture slot.In addition, needle 24 includes rib 36 which enables the suture needleto be inserted into the blood vessel 31 by a pushing in action.

[0065]FIGS. 5A through 5H diagrammatically illustrate variousmodifications of suture toggle 14. FIG. 5A diagrammatically illustratessuture toggle 14 having a protruding leg 16 which protrudes outboardfrom the toggle opposite suture thread 12. Particularly, toggle 14 is atoggle bar. As used herein, the term “toggle^(t)” refers to a piece or adevice for holding or securing suture thread 12. The term “toggle” alsoencompasses the concept that it is a cross piece attached to the end ofsuture thread 12 in order to prevent slipping or removal of the suture.The following Bar Shape Table provides some illustrative examples of thegeometric shape of the toggle bar.

[0066] Bar Shape Table

[0067] a straight piece of suture material which is longer than it iswide

[0068] rectangular

[0069] oblong

[0070] elliptical

[0071] an elongated cylinder

[0072] As used herein, the term “bar” refers to a straight piece whichis longer than it is wide. As shown in FIG. 5A, leg 16 is formed from apartially separated segment of toggle bar 14. Remaining segment 18continues to form part of the toggle bar basic shape.

[0073]FIG. 5B shows a depending protruding leg 38 which protrudesinboard toward suture thread 12. Leg 38 is cut away or formed fromtoggle bar segment 39. Leg 38 is retained by and captured within openended toggle slot 30 of needle 24. Gap 20 between leg 38 and toggleremainder section 39 is one of the important features.

[0074]FIG. 5C diagrammatically illustrates toggle suture 14 including atab 40 depending from inboard surface 41 of suture toggle 14. Inboardsurface 41 is integral with or attached to suture terminal end 13.Surface 41 is inboard with respect to suture thread 12.

[0075]FIG. 5D diagrammatically shows tab 40 depending toward suturethread 12. FIG. 5D shows tab 40 consisting of either a solid triangularbody, a finger or a conical body. The width of tab 40 is smaller thansuture toggle 14. Protruding tab 40 has a raised terminal edge 42, seeFIG. 5E, which faces away from suture thread 12. Tab 40 coacts with openended slot 30 of suture delivery needle 24 (see for example FIG. 4B).The tab fits in toggle slot 30. In a different embodiment, suture slotmay be placed 90 degrees from toggle slot 30 (see FIG. 9C) to provideclearance of the tab from the thread during withdrawal of needle 24.

[0076]FIG. 5F diagrammatically illustrates suture toggle 14 carrying twotabs 40, 43 depending from inboard surface 41 of suture tab 14.

[0077]FIG. 5G diagrammatically shows tab 40 as a solid triangular body.Suture toggle 14 is also a solid rectangular body without chamferededges.

[0078]FIG. 5H diagrammatically illustrates suture toggle 14 from theperspective of section line 5H′-5H″ in FIG. 5G. Tab 40 has a raisedterminal edge 42 which faces towards suture thread 14. Accordingly, thetab can either face away from suture thread 12 as in FIG. 5E or towardssuture thread 12 as in FIG. 5H.

[0079]FIG. 6 diagrammatically shows suture toggles 14 and 14 a disposedat opposite terminal ends of suture thread 12. Suture thread 12 has alength Is which is, in one embodiment, about 16-18 inches. FIG. 6 alsoshows that suture toggle 14 has been deployed beneath body layer 31.

[0080]FIG. 7 diagrammatically shows deployed suture toggles 14 and 14 aon blood vessel wall 31. The suture toggles are deployed beneatharterial wall 31. Arterial wall 31 is illustrated as having arterialpuncture site 44. Suture toggles tabs 14, 14 a are deployed on eitherside of puncture side 44. Suture thread 12 connects suture toggles 14,14 a. In operation, the surgeon or physician ties off suture thread 12thereby closing arterial puncture site 44.

[0081]FIGS. 8A, 8B and 8C diagrammatically illustrate suture toggle 14with a protruding leg 16 along one side. Particularly, FIG. 8Adiagrammatically shows suture toggle 14 as a toggle bar with chamfersalong its side edges. One of the chamfers is identified as chamfer 15. Aprotruding leg 16 is formed by partly separating toggle 14 fromremaining toggle segment 18. This creates an open mouth 20 which isdisposed in the toggle slot in needle 30. See FIG. 2A.

[0082]FIG. 8B shows a top view of suture toggle 14 and clearly showsthat protruding and extending leg 16 is formed by partially separatingleg 16 from the remaining toggle body portion 18. The generally solidbody rectangular toggle bar 14 has sides 2, 3, 4 and 5 which aregenerally in parallel planes with respect to the axial centerline ofsuture thread 12 if the thread were laid out straight. Items protrudingfrom toggle bar walls 2, 3, 4, 5 are normal (perpendicular) to thesuture thread.

[0083]FIG. 8C shows a toggle end view and toggle mouth 20.

[0084] FIGS. 9A-9D show needle 24 with and without a retained togglesuture. FIG. 9A shows toggle slot 30 in needle 24 located approximatelymidway along piercing terminal edge 28 of needle 24. The toggle slot canbe repositioned dependent upon the size of the suture, the leg or tab,and the item to be sutured. FIG. 9B also shows toggle slot 30 of needle24 approximately midway along needle piercing edge 28. FIG. 9B alsoshows suture toggle 14 deployed in toggle slot 30. Suture thread 12 runsor passes through the lumen 26 of needle 24.

[0085] In FIG. 9B, slot 30 retains protruding leg 16 which protrudesfrom side edge 5 of the toggle bar. The side edge protruding leg 16 isshown in FIGS. 8A-8C. Leg 16 protrudes normal or perpendicular to suturethread 12.

[0086]FIG. 9C shows needle 24 having toggle slot 30 and suture threadslot 34. Suture thread slot 34 is formed or created approximately 90degrees from toggle slot 30.

[0087]FIG. 9D shows suture toggle 14 with a side end protruding leg 16wherein suture thread 12 runs through suture slot 34 of needle 24.

[0088]FIG. 10A shows suture toggle 14 deployed in arterial wall 31.

[0089]FIG. 10B is a detailed view showing suture toggle 14 deployed onan inboard surface of arterial wall 31. Currently, it is believed thatthe toggle bar with a leg or tab protruding from bar side 2, 3, 4 and 5is preferable.

[0090]FIG. 8B shows toggle bar 14 with side surfaces 2, 3, 4 and 5. Itis currently believed that a tab or leg protruding from one of the sidesurfaces is better suited than an outboard extending tab or leg (seeFIG. 5A) or a depending tab or leg (see FIG. 5B). The depending leg orthe depending tab may injure an arterial 31 in certain situations. Whentoggle anchoring is required, the depending leg or wire is preferred. Anupstanding or outboard tab or leg may impede blood flow. However, insome applications, these tab-leg configurations may be beneficial if itachieves better attachment by the suture toggle on the body structure,tissue or organ. A side leg or tab is currently thought to be betterthan an outboard leg or tab (see outboard leg 16 in FIG. 1A) because anoutboard protruding leg or tab may further complicate and impede bloodflow or fluid flow through the bodily structure, tissue or organ,particularly if the structure is an artery or a vein.

[0091]FIG. 11A diagrammatically shows suture toggle 14 having aprotruding tab 40 protruding from side surface 5 of the toggle bar.

[0092]FIG. 11B shows protruding legs or arms 50, 51 protruding from sidesurface 5 of toggle bar 14. A plurality of legs or tabs may be utilized.FIG. 11C shows toggle 14 with a generally planar triangular tab 40protruding from side face 5. Tab 40 in FIG. 11A is generally conical instructure with squared off surfaces. Tab 40 in FIG. 11C is generally aplanar triangle.

[0093]FIG. 12 shows suture toggle 14 with a triangular tab deployedwithin the lumen of delivery needle 24. Tab 40 of toggle 14 protrudesfrom toggle slot 30. Suture 12 is deployed such that it exits lumen 26of needle 24 near proximal edge region 52 of piercing terminal edge 28of needle 24. Proximal region 52 may be rounded or smoothed to avoidcutting suture thread 12.

[0094]FIG. 13A and 13B diagrammatically illustrate suture toggle 14configured as a cylindrical bar with a laterally protruding leg 16. Leg16 is also cylindrically shaped and protrudes laterally from toggle barelement 18. Leg 16 is generally normal to suture thread 12. Leg 16 isnot cut from or separated from the cylindrical toggle bar.

[0095]FIG. 13C diagrammatically illustrates toggle bar 14 at an angle 9with respect to the axial centerline of suture thread 12. In thisconfiguration, the acute angle 7 between angled toggle bar 14 and suturethread 12 is disposed within suture slot 30 of needle 24. This angulatedconfiguration may enable long T-shaped bar deployment in needle 24. Theterm “long T-shaped” refers to the length of sides 3,5 (see FIG. 8B)relative to the cross-sectional dimension of suture thread 12. Thisimplementation may also avoid the use of protruding legs, tabs ormembers.

[0096] FIGS. 14-20 diagrammatically illustrate various suture deliverysystems.

[0097]FIG. 14A diagrammatically shows suture delivery system 60 whichincludes a basic or central tube 62 which runs over a guide wire 64.Guide wire 64 typically is not part of the suture delivery system. Theillustrated delivery system in FIG. 14A is used to close puncture woundsmade during catheterization. Guide wires 64 are used during such medicalprocedures. For purposes of explanation, suture delivery needles 66, 68carry suture toggles and suture threads generally shown and discussedearlier in connection with FIGS. 1-13.

[0098]FIG. 15A shows suture needle 66 having a piercing edge 67 and atoggle slot 69. FIG. 15B diagrammatically illustrates a side view ofsuture needle 66.

[0099] Returning to FIG. 14A, base tube 62 rides over guide wire 64 inorder to properly place suture needles 66, 68 on either side of arterialpuncture 44 shown in FIG. 7. Suture needles 66, 68 have piercing ends67, 67 a which are laterally deployed a distance 69 from base centraltube 62. In this suture delivery system, suture needles 66, 68 are madeof metal having a shape memory such that when needle end segment 70 isfree from needle containment or retaining structure 72, the distal endsof needles 66, 68 spring laterally outward a distance 69.

[0100] Needles 66, 68 run and protrude through needle retainer body 72and also protrude proximally from proximal end 74 of retainer 72 towardsthumb nut set 76. Proximal needle ends 75, 77 for needles 66, 68 aregenerally near thumb nut set 78.

[0101] Needle retention structure 72 has a proximal tube member 80 suchthat tube 80 runs over central tube 62. The operator moves needleretainer structure 72 by moving thumb nut set 78 in the direction shownby arrow 82. As shown in FIG. 16D, proximal tube 80 (attached to needleretainer body 72) has longitudinal slots 73 a, 73 b. Needles 66, 68 areattached to base or center tube 62. Hence, when tube 62 is stationaryand needle retainer 72 is moved, needles 66,68 are either exposed (FIG.14A) or fully retained and covered (FIG. 14B).

[0102]FIG. 14B shows that needle retaining structure 72 has been pushedforward such that proximal ends 75, 77 of needles 66, 68 are proximateor near thumb nut set 78. Piercing edges 67, 67 a are disposed at, nearor below distal edges 79, 81 of needle retention structure 72. When thestructure delivery system 60 is placed on guide wire 64 and placed neararterial puncture site 44 (FIG. 17), thumb nut set 78 (mounted on tab 80and retainer 72) is then withdrawn in a direction opposite arrow 72 inFIG. 14A, and distal end 70 of needles 66, 68 are then exposed andsprung laterally outward due to the memory shape of the needles. Thesurgeon then places the distal end of tube 62 into arterial puncture 44(FIG. 17) and continues to move delivery system 60 down guide wire 64until he or she sees a flash of blood when piercing ends 67, 67 a ofneedles 66, 68 pierce arterial wall 31. A flashback may also occurthrough base tube 62. Toggle insertion generally occurs at sites 83, 85(FIG. 17). The surgeon then withdraws the needles thereby leaving thetoggle ends of the sutures on the inside arterial wall 31. The surgeoncan then close the arterial puncture after removal of guide wire 64 in amanner described above in connection with FIG. 7.

[0103]FIGS. 16A, 16B and 16C show different structures for needleretention structure 72. In FIG. 16A, retention structure 72 is generallycircular in configuration. The structure contains left and rightpassages 82, 84 within which pass needles 66, 68. A central passage 86permits passage of base tube 62.

[0104] In FIG. 16B, needle retention structure 72 is elliptical oroblong. In FIG. 16C, needle retention structure 72 includes a centralcylindrical body 88 and two side bodies 90, 92. Side body 90 has a lumenthrough which passes needle 66. Side body 92 includes a lumen throughwhich passes needle 68. Central body 88 includes a lumen through passescentral or base tube 62.

[0105]FIG. 17 shows that a typical size of the large artery havingdimension da which is approximately 7 mm (inside diameter) and puncturesite 44 has an approximate opening size ap of approximately 2-3 mm. Thelateral distance between respective piercing edges 37, 37 a of needles66, 68 is approximately 5-6 mm. The lumen of the suture toggle deliveryneedles 66, 68 is approximately 0.02 mm. Accordingly, the puncture forthe suture toggles is small compared with the size of the arterialpuncture which in turn is smaller than the inside diameter da of largeartery 31.

[0106]FIG. 18 diagrammatically shows delivery system 60 including ashaped element 94 which forces needles 66, 68 to move laterally in thedirection of arrows 96 a and 96 b outboard and away from central tube62. Shape element 94 acts as a cam surface and needles 66,68 follow theproximal cam surface of the shape 94. The proximal end segments ofneedles 66,68 are attached to outer tube 80 which is further attached toscrew set 78. When outer tube 80 moves forward and aft over central tube62, the distal ends of needles 66, 68 move forward and aft over camshape surface 94. Cam shape element 94 is mounted on central base tube62. The following Needle Delivery Flare Table describes some shapes ofthe cam shape 94. Needle Delivery Flare Table ball olive oblongfrustoconical angled ribs (with apex at a proximal end)

[0107]FIG. 19 diagrammatically shows an exploded view of delivery system60. Thumb screw set 78 is attached to the proximal end of needlecarrying tube 80. Needles 68, 68 are attached to carrying tube 80.

[0108]FIG. 20A shows needles 66, 68 from the perspective of section line20A′-20A″ in FIG. 19. The attachment of needles 66, 68 to needlecarrying tube 80 is shown in a cross-sectional view in FIG. 20B from theperspective of section line 20B′-20B″ in FIG. 19. The lumen 80 a ofneedle carrying tube 80 is large enough to accommodate central tube 62.Central tube 62 extends through needle carrier tube 80.

[0109] Needles 66, 68 and needle carrying tube 80 are placed overcentral or base tube 62. Guide wire 64 extends through lumen 63 ofcentral tube 62 when the system is deployed and in use.

[0110]FIG. 20C shows a cross-sectional view of central tube 62 from theperspective of section line 20C′-20C″ in FIG. 19. Needle retention body72 is mounted on central tube 62.

[0111] Needle retention body or structure 72 is mounted on central tube62. A cross-sectional view of one embodiment of needle retention body 72is shown in FIG. 20D. FIG. 20D is a view from section lines 20D′-20D″ inFIG. 19. Needle cam shape 94 is attached to the distal end of centraltube 62 slightly beyond needle exit ports 98, 99 of needle retentionbody 72. It should be noted that needle retention body 72 may take oneor more of the shapes illustrated above in connection with FIGS. 16A,16B and 16C.

[0112] To construct the delivery system shown in FIG. 19, needlecarrying tube 80 and needles 66, 68 are placed over central tube 62.Needles 66,68 are fed into needle entrance ports 97 a, 97 b. Needles 66,68 are placed into the left and right side needle lumens of needleretention structure 72 until they are proximate needle exit ports 98,99. Thereafter, thumb nut set 76 is placed on the proximal end ofcentral tube 62 by an appropriate attachment means (e.g., a thread).Accordingly, face 101 of set 76, along section lines 102′-102″ is nearor adjacent face 103 of set 78 at section lines 104′-104″ which is theproximal end of thumb nut set 78. In a preferred embodiment, thumb nutset 78 may cooperate with thumb nut set 76 to lock the needle deliverysystem and suture delivery system together prior to deploying the systemon guide wire 64. After deployment, the system takes the configurationshown above in connection with FIG. 14B except central tube 62 includesa needle cam shape 94. This cam shape is absent from FIG. 14B.

[0113] At the time of suture toggle deployment, needle carrying tube 80is moved distally while central tube 62 remains stationary therebycausing needles 66, 68 to leave exit ports 98, 99 and move over needlecam surface shape 94. At that time, the distal ends of needles 66, 68move laterally outboard (relative to the axial center line) in thedirection shown by arrows 96 a, 96 b in FIG. 18 until the piercingsurfaces of needles 66, 68 are distally beyond the needle cam shape 94.At that time, the operator inserts the distal end of central tube 62into arterial puncture 44 shown in FIG. 17. Thereafter, needles 66, 68pierce arterial wall 31, deposit the toggles in the artery's lumen andat the underside of arterial wall 31 and the operator withdraws theneedles by moving thumb nut set 68 proximally with respect to centraltube 62 which is preferably held stationary. This causes needles 66, 68to withdraw and laterally collapse since cam surface shape 94 no longerforces the distal end of the needles to protrude laterally outwardbeyond central tube 62. The needles are also drawn into needle retentionbody 72. When the needles' terminal ends are at or near exit ports 98,99, the entire delivery system is withdrawn and the surgeon or physicianties off the suture wire as shown in FIG. 7.

[0114] FIGS. 21-22 diagrammatically illustrate a toggle suture made ofwire. This wire may be stainless steel wire. The toggle may also bememory shape metal. In contrast, the sutures discussed above inconnection with FIGS. 1-13 are made of nylon or other syntheticbiocompatible material.

[0115]FIG. 21A shows suture wire 110 having a wire element toggle 114 atsuture terminal end 113. The wire is typically stainless steel but maybe an other type of biocompatible metal material. Wire element toggle114 includes a double strand segment 116. Wire element toggle 114 is 16b angularly disposed, that is, disposed over angle 118 with respect tothe axial central line of suture wire 110. In addition, wire elementtoggle 114 includes a depending wire tip section 118.

[0116]FIG. 21B shows wire element toggle 114 disposed on an inboard sideof body structure, tissue or organ layer 31. Depending wire element 118protrudes into body layer 31 thereby locking or anchoring the togglesuture in place.

[0117]FIG. 21C shows wire suture 110 with a wire element toggle 114being normal with respect to the suture wire. The angular disposition oftoggle 114 to the axial centerline of laid-out suture wire 110 isrelated to the needle delivery system and the spring action and toggleor latch action of the suture toggle.

[0118]FIG. 21D shows that depending leg 118 is angularly disposed atangle 121 with respect to the central axis of wire element toggle 114.The angular position is related to the needle delivery system and thedegree of locking necessary on bodily structure 31.

[0119]FIG. 21E shows suture wire 110 having a wire body 122 (about16″-18″) and having toggle elements 114 a, 114 b attached to sutureterminal ends 113 a, 113 b.

[0120]FIG. 21F shows wire element toggle 114 attached by welding orother type of mounting mechanism to suture terminal end 113.

[0121]FIG. 22A shows needle delivery system 124 which retains wireelement toggle 114 and wire suture 112. Toggle element 114 includes anopen loop 135 and a linear segment 136. Linear segment 136 rests againstthe proximal end wall of a needle slot 130. Open loop toggles are shownin FIGS. 21E, 22A, C and D.

[0122]FIG. 22B shows needle 124 having a toggle needle slot 130 and wireelement toggle 114 having a depending leg 118 resting on toggle needleslot 130. Suture wire 110 is disposed in lumen 126 of needle 124. Leg118 is used to mount suture wire 110 in the delivery needle. Legs 119are shown in FIGS. 21A, 21B, 21D and 21F.

[0123]FIG. 22C shows toggle element 114 with open loop 135 disposed intoggle needle slot 130.

[0124]FIG. 22D shows wire element toggle 114 in toggle slot 130 ofneedle 124. Needle 124 also includes a suture slot 134 through whichruns wire suture 110. Wire element toggle 114 is retained within toggleslot 130 via its open loop. The operation of the wire suture and wireelement toggle is substantially similar to the suture toggle discussedabove in connection with FIGS. 1-13. The operation and deployment of thesuture toggle and the suture needle is also similar to that discussedabove in connection with FIGS. 1-13.

[0125]FIGS. 23A, 23B and 23C diagrammatically show a delivery system 210used in connection with fascia 220 to deploy suture toggles in a mannerdiscussed above in connection with FIGS. 1-13 and 21-22. The deploymentdevice shown and described in connection with FIGS. 23-24 is typicallyused in laproscopic surgery. However, it maybe used whenever a surgeonneeds to suture fascia.

[0126] Delivery system 210 includes handle 222 and central tube 224which carries thread 226 at its distal end. Thread 226 coacts withthreads on an inboard surface of collar 228. Collar 228 is attached tosuture needles 230,232. Suture needles 230,232 move within needlepassages in needle retention body 234. This mechanical theory andfeature is generally discussed above in connection with needle retentionbody 72 and FIGS. 14A and 18.

[0127] Central body or tube 224 has a mid-section 224 a and a distalsection 224 b. At the distal end of distal section 224 b, a radiallylarge fascia lift element 240 is mounted. A plunge cone 242 is mountedto the distal end of enlarged lift segment 240. Fascia is lifted by theproxial, peripheral radial lip 240 a of lift element 240.

[0128]FIG. 23B diagrammatically shows an operational state of deliverysystem 210. The distal ends 230 a, 232 a of needles 230, 232 protrudeaxially beyond the distal end of needle retainer 234. In operation, thesuture toggles are deposited in the fascia by rotational movement ofbody 224 to collar 228 translated into axial movement and needle ends230 a, 232 a are withdrawn by counter rotation of central tube 224thereby moving collar 228 in a proximal direction. Withdraw of thesuture needles causes the suture toggles to remain embedded in thefascia.

[0129]FIG. 23C shows a delivery system 210 with suture wires 110 a, 110b disposed outboard of suture needle ends 230 a,232 a. The suture wiresare run through capture channels 250,252 on either side of needleretention body 234.

[0130]FIG. 23D is a diagrammatic cross-sectional view from theperspective of section lines 23D′-23D″ in FIG. 23C. Suture capture body252 captures suture wire 110 b in a channel 254. Upon deployment of thetoggle suture in the fascia, the physician simply moves the suture wireoutboard of the channel 254 and closes the site.

[0131]FIGS. 24A, 24B and 24C diagrammatically illustrate the operationof delivery system 210. In FIG. 24A, cone 242 and fascia support or liftelement 240 have been inserted into a hole or cavity formed in fascia220. The surgeon or physician allows the fascia to rest thereby closingthe hole about distal cental rod segment 224 b.

[0132] In FIG. 24B, the physician gently raises delivery system 210 inthe direction shown by arrow 275. Lift element lip 240 a causes fascia220 to rise thereby lifting fascia 220 above underlying tissue elements220 a. Further, the physician rotates central handle 224 with respect tocollar 228 thereby causing suture needles 230 a, 232 a to protrudebeyond the distal end of needle retention body 234.

[0133] In FIG. 24C, the physician has completely rotated handle 224thereby completely deploying needle ends 230 a, 232 a through fascia220. Upon complete deployment of the toggle carrying sutures, the suturetoggles engage the inboard edge or side of fascia 220 preferably in theinterstitial space between underlying material 230 a. The toggles arecaught by the fascia, leave the toggle carrying needles, latch onto theinboard surface of fascia 220 and remain in the fascia. The surgeon thencounter rotates handle 224 with respect to collar 228 therebywithdrawing suture needle ends 230 a, 232 a from fascia 220.Essentially, needles 230, 232 are withdrawn and recaptured by needleretention body 234. The surgeon then gently withdraws fascia liftelement 240 from fascia 220. The toggles are embedded in the inboardsurface of the fascia and the surgeon can then close the fascia.

[0134]FIGS. 25A, B, C and D diagrammatically illustrate a wire togglewith a wire suture 310 and a wire toggle element 312. Toggle element 312is configured as a hook with a crook or bend element 316 (0.008 orgreater), an angled body segment 314 and an end segment 318. End segment318 is generally in a plane parallel with respect to the axialcenterline of wire suture 310 assuming the suture is laid out straight.the length It of hook end 318 is approximately 0.04. This configurationlocks onto the inboard surface of the bodily structure after the wiresuture is deployed beneath the surface. See generally FIG. 25D.

[0135]FIG. 25B illustrates toggle wire element 312 with a stepped radiusor curve consisting of proximal angled segment 320, normal segment 322(having a running length wr of about 0.020) and angled segment 323. Hookspang from suture 310 to end segment 318 is about 0.60. FIG. 25C showshooked toggle 312 deployed in a delivery needle 324. In the illustratedembodiment, the needle does not have a suture slot.

[0136]FIG. 25D illustrates the deployment of hook toggles 312, 312 a andthe integral or attached wire sutures 310, 310 a twisted or crossed. Inthe configuration, the wire sutures are enabled to close the illustratedgap in body structure 340.

[0137] The claims appended hereto are meant to cover modifications andchanges within the scope and spirit of the present invention.

What is claimed is:
 1. A self securing suture comprising a suture having at least one terminal end and a toggle, formed of suture material, at said terminal end.
 2. A suture as claimed in claim 1 wherein said suture is a thread of suture material and said toggle is a bar disposed one of generally normal to said suture thread and at an angle with respect to said suture thread.
 3. A suture as claimed in claim 2 wherein said suture has an outside diameter and said toggle has a generally solid rectangular shape and a width, a length and a depth, said width being substantially similar to said outside diameter of said suture and said length, normal to said suture thread, is at least five times larger than said outside diameter of said suture.
 4. A suture as claimed in claim 1 wherein said toggle is a bar having a width, a length and a depth, and said toggle includes an extending leg protruding from said toggle bar.
 5. A suture as claimed in claim 4 wherein said protruding leg is formed from a partially separated segment of said toggle bar.
 6. A suture as claimed in claim 4 wherein said protruding leg extends outboard from said toggle bar away from said terminal end of said suture.
 7. A suture as claimed in claim 4 wherein said suture is a thread of suture material and said leg extends outboard substantially normal to said suture thread.
 8. A suture as claimed in claim 4 wherein said suture is a thread of suture material and said leg extends outboard from said toggle bar and inboard towards said suture thread.
 9. A suture as claimed in claim 8 wherein said toggle bar has opposing first and second ends, said leg and said toggle bar form a open catch mouth leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 10. A suture as claimed in claim 1 wherein said toggle is a bar having a width, a length and a depth, and said toggle includes an extending tab protruding from said toggle bar.
 11. A suture as claimed in claim 10 wherein said protruding tab extends outboard from said toggle bar away from said terminal end of said suture.
 12. A suture as claimed in claim 10 wherein said suture is a thread of suture material and said tab extends outboard substantially normal to said suture thread.
 13. A suture as claimed in claim 10 wherein said suture is a thread of suture material and said tab extends outboard from said toggle bar and inboard towards said suture thread.
 14. A suture as claimed in claim wherein said toggle bar has opposing first and second ends, said tab is an extender bar protruding from said toggle bar and forming a open catch mouth leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 15. A suture as claimed in claim 10 wherein said toggle bar has opposing first and second ends, said tab is one of a solid triangular body, a finger and a conical body extending from a suture thread inboard toggle bar surface towards said suture thread, said tab having a raised terminal edge which faces away from said suture thread.
 16. A suture as claimed in claim 15 wherein said toggle bar carries a plurality of tabs.
 17. A suture as claimed in claim 1 wherein said suture includes two terminal ends coupled together by a suture thread and the self securing suture includes respective toggle at each suture terminal end.
 18. A suture as claimed in claim 2 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 19. A suture as claimed in claim 4 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 20. A suture as claimed in claim 7 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 21. A suture as claimed in claim 10 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 22. A suture as claimed in claim 12 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 23. A suture as claimed in claim 1 wherein said suture is metal wire and said toggle is a wire element disposed on said suture terminal end at an angle with respect to said suture wire.
 24. A suture as claimed in claim 23 wherein said wire element toggle includes a double strand segment between said suture wire and a terminal end of said wire element toggle.
 25. A suture as claimed in claim 24 wherein said wire element toggle includes a depending wire tip section angularly disposed with respect to said wire toggle element.
 26. A suture as claimed in claim 23 wherein said wire element toggle is attached to said suture wire and said wire toggle element includes a depending wire tip section angularly disposed with respect to said wire toggle element.
 27. A suture as claimed in claim 23 wherein said wire toggle element defines an open loop element.
 28. A suture as claimed in claim 27 wherein said open loop element defines a linear segment thereon.
 29. A suture as claimed in claim 28 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture.
 30. A suture as claimed in claim 23 wherein said wire element toggle is attached to said suture wire and wherein said wire toggle element defines an open loop element.
 31. A suture as claimed in claim 30 wherein said open loop element defines a linear segment thereon.
 32. A suture as claimed in claim 31 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture.
 33. A suture as claimed in claim 26 wherein said depending wire tip section is substantially normal to said wire suture.
 34. A suture as claimed in claim 23 wherein said wire suture includes two terminal ends coupled together by a suture wire body and the self securing suture includes a respective toggle at each wire suture terminal end.
 35. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a suture having at least one terminal end and a toggle, formed of suture material, at said suture terminal end, and an extending leg protruding from said toggle, said leg adapted to seat within said needle slot.
 36. A suture delivery system as claimed in claim 35 wherein said suture is a thread of suture material and said toggle is a bar disposed one of generally normal to said suture tread and at an angle with respect to said suture thread.
 37. A suture delivery system as claimed in claim 35 wherein said toggle is a bar having a width, a length and a depth, and said extending leg protrudes from said toggle bar.
 38. A suture delivery system as claimed in claim 37 wherein said suture is a thread of suture material and said leg extends outboard substantially normal to said suture thread.
 39. A suture delivery system as claimed in claim 38 wherein said toggle bar has opposing first and second ends, said leg and said toggle bar form a open catch mouth leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 40. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a suture having at least one terminal end and a toggle, formed of suture material, at said suture terminal end, and an extending tab protruding from said toggle, said tab adapted to seat within said needle slot.
 41. A suture delivery system as claimed in claim 40 wherein said suture is a thread of suture material and said tab extends outboard substantially normal to said suture thread.
 42. A suture delivery system as claimed in claim 41 wherein said toggle is a bar and said toggle bar has opposing first and second ends, said tab is one of a solid triangular body, a finger and a conical body extending from a suture thread inboard toggle bar surface towards said suture thread, said tab having a raised terminal edge which faces away from said suture thread.
 43. A suture delivery system as claimed in claim 42 wherein said toggle bar carries a plurality of tabs.
 44. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a metal wire suture having at least one terminal end and a wire element toggle disposed on said suture terminal end at an angle with respect to said suture wire and a depending wire tip section angularly disposed with respect to said wire toggle element, said wire tip section adapted to seat within said needle slot.
 45. A suture delivery system as claimed in claim 44 wherein said wire element toggle includes a double strand segment between said suture wire and a terminal end of said wire element toggle.
 46. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a metal wire suture having at least one terminal end and a wire element toggle disposed on said suture terminal end at an angle with respect to said suture wire and a an open loop element formed on said wire element toggle, said open loop element adapted to seat within said needle slot.
 47. A suture delivery system as claimed in claim 46 wherein said open loop element defines a linear segment thereon, said linear segment adapted to seat in said needle slot.
 48. A suture delivery system as claimed in claim 46 wherein said wire element toggle is attached to said suture wire.
 49. A suture delivery system as claimed in claim 48 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture 